Jobs and Careers
ME
Sr. Quality Engineer
MedtronicUnited Statesfull_timeVerifiedPosted 9 Jun 2025
💰 $145,200/yr($130,600/yr – $145,200/yr)
About the role
Position Description:
Sr. Quality Engineer for Covidien, LP (a Medtronic company) located in Irvine, CA. Provide quality engineering support for the successful development of Neurovascular products. Ensure design control requirements are met and products are developed and manufactured in accordance with applicable industry standards, regulatory requirements and customer requirements. Work with vascular devices, embolic coils, stents, catheters, balloons, aspiration devices, coatings and guide wires to ensure quality products. Utilize Statistical analysis tools including DOE (Design of Experiments), SPC (Statistical Process Control), ANOVA (Analysis of Variance), t-test, Process Capability, Confidence & Tolerance interval analysis with proficiency in Minitab. Utilize process control tools, statistical sampling, and other analytical techniques to maximize the quality and flow of product through the production line. Coordinate Product and Process risk utilizing Process Failure Mode Effects and Criticality Analysis (PFMECA) and Design Failure Mode Effects and Criticality Analysis (DFMECA). Navigate government and industry standards to include FDA 21CFR part 820, ISO13485, ISO14971, Good Manufacturing Practices (GMP)and Good Documentation Practices (GDP). Provide Process Verification & Validation for product quality, including development and execution of protocols Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) and TMV (Test Method Validations). Coordinate root cause analysis using various quality tools (5 Whys, 6M and Ishikawa (Fishbone) Diagram) for failed product or processes. Participate in CAPA (Corrective and Preventive Actions) and implementation of corrective and preventive actions as necessary. Identify Critical to Quality (CTQ) product features, procedures for Inspecting testing and evaluating the precision, accuracy of products, production equipment and sampling methods as well as interpreting engineering drawing and GD&T (Geometric Dimensioning and Tolerancing). Relocation assistance not provided. #LI-DNI
*Position works a hybrid model and will be onsite in Irvine, CA location – 4/5 days per week. May support 2nd Shift operations 3:00 PM to 12:00 AM.
NOTICE: Pursuant to 20 C.F.R. § 656.10, you are hereby notified that an Application for Permanent Employment Certification will be filed for the job opportunity below. Any individual may provide documentary evidence bearing on this application, with information on available workers and information on wages and working conditions, to the Certifying Officer at the U.S. Department of Labor as follows:
Certifying Officer
U.S. Department of Labor
Employment and Training Administration
Office of Foreign Labor Certification
200 Constitution Avenue NW, Room N-5311
Washington, DC 20210
Basic Qualifications:
Master’s degree in Biomedical Engineering, Mechanical Engineering, Industrial Engineering, or related field and two (2) years of experience as a quality engineer, manufacturing engineer, or in related occupation in quality or manufacturing engineering. Or, Bachelor’s degree in Biomedical Engineering, Mechanical Engineering, Industrial Engineering, or related field and five (5) years of experience as a quality engineer, manufacturing engineer, or in related occupation in quality or manufacturing engineering. Must possess at least two (2) years’ experience with each of the following: DOE, SPC, ANOVA (Analysis of Variance), t-test, Process Capability, Confidence & Tolerance interval analysis;
Product and Process risk utilizing DFMECA and PFMECA; FDA 21CFR 820, ISO13485, ISO14971 and GDP; Six sigma and lean principles; Process Verification & Validation to include IQ, OQ, PQ and TMV; Root cause analysis using 5 Whys, 6M and Ishikawa (Fishbone) Diagram; CAPA investigation and corrective action implementation; Identifying CTQ product features and sampling methods; Interpreting engineering drawing and GD&T.
Position works a hybrid model and will be onsite in Irvine, CA location – 4/5 days per week. May support 2nd Shift operations 3:30 PM to 12:00 AM. Relocation assistance not provided.
The position is located at Covidien LP (a Medtronic company), 9775 Toledo Way, Irvine, CA 92618.
Salary: $130,600 to $145,200 per year
THIS POSITION QUALIFIES FOR THE MEDTRONIC EMPLOYEE REFERRAL BONUS PROGRAM AT THE LEVEL OF $1,000. Refer to the program guidelines located at InternalJobs.Medtronic.com.
#LI-DNI
The following benefits and additional compensation are available to those regular employees who work 20+ hours per week: Health, Dental and vision insurance, Health Savings Account, Healthcare Flexible Spending Account, Life insurance, Long-term disability leave, Dependent daycare spending account, Tuition assistance/reimbursement, and Simp
Sr. Quality Engineer for Covidien, LP (a Medtronic company) located in Irvine, CA. Provide quality engineering support for the successful development of Neurovascular products. Ensure design control requirements are met and products are developed and manufactured in accordance with applicable industry standards, regulatory requirements and customer requirements. Work with vascular devices, embolic coils, stents, catheters, balloons, aspiration devices, coatings and guide wires to ensure quality products. Utilize Statistical analysis tools including DOE (Design of Experiments), SPC (Statistical Process Control), ANOVA (Analysis of Variance), t-test, Process Capability, Confidence & Tolerance interval analysis with proficiency in Minitab. Utilize process control tools, statistical sampling, and other analytical techniques to maximize the quality and flow of product through the production line. Coordinate Product and Process risk utilizing Process Failure Mode Effects and Criticality Analysis (PFMECA) and Design Failure Mode Effects and Criticality Analysis (DFMECA). Navigate government and industry standards to include FDA 21CFR part 820, ISO13485, ISO14971, Good Manufacturing Practices (GMP)and Good Documentation Practices (GDP). Provide Process Verification & Validation for product quality, including development and execution of protocols Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) and TMV (Test Method Validations). Coordinate root cause analysis using various quality tools (5 Whys, 6M and Ishikawa (Fishbone) Diagram) for failed product or processes. Participate in CAPA (Corrective and Preventive Actions) and implementation of corrective and preventive actions as necessary. Identify Critical to Quality (CTQ) product features, procedures for Inspecting testing and evaluating the precision, accuracy of products, production equipment and sampling methods as well as interpreting engineering drawing and GD&T (Geometric Dimensioning and Tolerancing). Relocation assistance not provided. #LI-DNI
*Position works a hybrid model and will be onsite in Irvine, CA location – 4/5 days per week. May support 2nd Shift operations 3:00 PM to 12:00 AM.
NOTICE: Pursuant to 20 C.F.R. § 656.10, you are hereby notified that an Application for Permanent Employment Certification will be filed for the job opportunity below. Any individual may provide documentary evidence bearing on this application, with information on available workers and information on wages and working conditions, to the Certifying Officer at the U.S. Department of Labor as follows:
Certifying Officer
U.S. Department of Labor
Employment and Training Administration
Office of Foreign Labor Certification
200 Constitution Avenue NW, Room N-5311
Washington, DC 20210
Basic Qualifications:
Master’s degree in Biomedical Engineering, Mechanical Engineering, Industrial Engineering, or related field and two (2) years of experience as a quality engineer, manufacturing engineer, or in related occupation in quality or manufacturing engineering. Or, Bachelor’s degree in Biomedical Engineering, Mechanical Engineering, Industrial Engineering, or related field and five (5) years of experience as a quality engineer, manufacturing engineer, or in related occupation in quality or manufacturing engineering. Must possess at least two (2) years’ experience with each of the following: DOE, SPC, ANOVA (Analysis of Variance), t-test, Process Capability, Confidence & Tolerance interval analysis;
Product and Process risk utilizing DFMECA and PFMECA; FDA 21CFR 820, ISO13485, ISO14971 and GDP; Six sigma and lean principles; Process Verification & Validation to include IQ, OQ, PQ and TMV; Root cause analysis using 5 Whys, 6M and Ishikawa (Fishbone) Diagram; CAPA investigation and corrective action implementation; Identifying CTQ product features and sampling methods; Interpreting engineering drawing and GD&T.
Position works a hybrid model and will be onsite in Irvine, CA location – 4/5 days per week. May support 2nd Shift operations 3:30 PM to 12:00 AM. Relocation assistance not provided.
The position is located at Covidien LP (a Medtronic company), 9775 Toledo Way, Irvine, CA 92618.
Salary: $130,600 to $145,200 per year
THIS POSITION QUALIFIES FOR THE MEDTRONIC EMPLOYEE REFERRAL BONUS PROGRAM AT THE LEVEL OF $1,000. Refer to the program guidelines located at InternalJobs.Medtronic.com.
#LI-DNI
The following benefits and additional compensation are available to those regular employees who work 20+ hours per week: Health, Dental and vision insurance, Health Savings Account, Healthcare Flexible Spending Account, Life insurance, Long-term disability leave, Dependent daycare spending account, Tuition assistance/reimbursement, and Simp
Apply for this role
Generate a tailored application kit with a matched cover letter, interview prep, and CV highlights — in under 60 seconds.
Apply Now →Generate Application KitFree account required — sign up in 30s